MAUDE Adverse Event Report: SYNTHES SELZACH 2.7MM CANNULATED DRILL BIT/QC 160MM; INSTR, SURGICAL, ORTHOPEDIC, AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number 310.670

Device Problem Dull, Blunt (2407)

Patient Problem Sedation (2368)

Event Date 06/12/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that two (2) drill bits did not cut well during an open reduction internal fixation (orif) procedure on (b)(6) 2015.Another bit was available for use.Also during the procedure, a guide wire broke leaving pieces in the patient¿s body.A thirty (30) minute delay was noted.The surgeon performed the procedure without using a ct scanner because, the patient was pregnant.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a product investigation was performed ¿ the complaint condition for the two drill bits is confirmed as both have dull distal tips.Based on the returned condition of each device, it is most probable that the complaint condition is the result of accumulated wear over the 6 and 10 year lifespan of the devices.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.The drill bits are for pre-drilling prior to insertion of 3.5mm and 4.0mm cannulated screws.The device is referenced in the 3.5mm cannulated screw technique guide, the 4.0mm cannulated screw technique guide, and the small fragment locking compression plate (lcp) system technique guide.The returned drill bits were received intact.The distal tip and distal flutes of both devices are dull as reported.The connecting posts each show worn edges and the balance of each device is in working condition.Thus, the complaint condition is confirmed but cannot be replicated as the devices are already dull.A review of the current design drawing / manufactured revision was performed.The design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Technique guide recommends that cannulated drill bits should be inspected after every procedure and replaced if worn or damaged.Based on the returned condition of each device, it is most probable that the complaint condition is the result of accumulated wear over the 6 and 10 year lifespan of the devices.Dhr review ¿manufacturing site: (b)(4).Supplier: (b)(4).Manufacturing date: 29.Jul.2009.Expiry date: -.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (part number 310.670, 2.7mm cannulated drill bit/qc 160mm, lot number 423719).The subject device was received intact with the complaint condition of ¿dull distal tip.¿ the complaint condition was confirmed upon inspection.The distal tip and distal flutes of the device is dull as reported.The connecting post shows worn edges and the balance of the device is in working condition.Thus, the complaint condition is confirmed but cannot be replicated as the devices are already dull.A review of the current design drawing was performed.The design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned device was determined to be suitable for its intended use when employed and maintained as recommended.The technique guide recommends that ¿cannulated drill bits should be inspected after every procedure and replaced if worn or damaged.¿ based on the returned condition of the device, it is most probable that the complaint condition is the result of accumulated wear over the 6 lifespan of the device.The returned device was determined to be suitable for its intended use when employed and maintained as recommended.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.A review of the device history records has been requested.Manufacture site provided.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.7MM CANNULATED DRILL BIT/QC 160MM
• Type of Device: INSTR, SURGICAL, ORTHOPEDIC, AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4886454
• MDR Text Key: 6043854
• Report Number: 2520274-2015-14767
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.670
• Device Lot Number: 423719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention