MAUDE Adverse Event Report: SYNTHES TUTTLINGEN LAMINA SPREADER; FORCEPS,GEN & PLASTIC SURGERY

Catalog Number	389.265
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient identifier, date of birth and weight is not available for reporting.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Reporter phone number: (b)(6).The information in this complaint record reasonably suggests that a device malfunction did occur and regardless of misuse, the recurrence of this malfunction is likely to cause or contribute to a death or serious injury if it were to recur.The complainant reported that the spreader was not holding properly.Additional findings, part of a leaf spring from p/n 389.265 was observed to be missing/broken during ir completion.The broken piece is not returned with the complaint.This event is reportable, this will be reportable due to the device breaking intra-operative a review of the device history records has been attempted.The manufacturing date: week 07 in 2005 the dhr is no longer available in (b)(4) due to the age of the instrument (over 12 years old).The exact date of manufacture is unknown.Subject device has been received and a product investigation was completed: the following complaint device(s) was received by customer quality (cq): one t-handle t25 stardrive shaft f/matrix-standard (part number: 03.632.004, lot number: 7575336, mfg.Date: 07aug2014).One lamina spreader (part number: 389.265, lot number: a7oa07, mfg.Date: week 7 in 2005).During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, drawing review, and device history record (dhr) review were performed as part of this investigation.Upon visual inspection, the distal tip of the star-drive is stripped which may prevent the device from functioning as intended.Replication of the complaint condition is not applicable as it¿s already stripped.As for the laminar spreader one the leaf springs is broken (not returned) from the device which may prevent the device form tensioning as intended, additionally the other leaf spring is cracked and/or broken and is held in place by a washer and glue (done at the facility as synthes does not ship the device with either item).As the circumstances leading to the damage is not known, the definitive root cause could not be determined, however, the failure mode is consistent with the application of excessive force over the course of use.No product design issues or discrepancies were observed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, during a transforaminal posterior lumbar interbody fusion (tplif) with matrix system and mtf bone implant, the lamina spreader, which was used to perform the discectomy and distract the working area, was not holding properly.The surgeon requested another lamina spreader in order to complete the case.It seems like the hinge does not hold as well as it should.In addition, the surgeon was finalizing the position of one (1) of the matrix screws and found that the t-handle t25 stardrive shaft for matrix-standard was not working properly.The end of the distal tip of the screwdriver is slightly stripped.Nothing fell into the patient.Another same/like product was used.There was no surgical delay during the procedure.The patient was reported as stable.This complaint involves two (2) devices.Concomitant devices reported: matrix screw (part # unknown, lot # unknown, quantity # 1).This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional narrative: initial alert date was (b)(6) but we found out it was broken on (b)(6).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: LAMINA SPREADER
• Common Device Name: FORCEPS,GEN & PLASTIC SURGERY
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6500385
• Report Number: 9680938-2017-10067
• Device Sequence Number: 79064
• Product Code: GEN
• UDI-Device Identifier: 10705034775203
• UDI-Public: (01)10705034775203(10)A7OA07
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 389.265
• Device Lot Number: A7OA07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 04/24/2017; 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MATRIX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY 1