MAUDE Adverse Event Report: BIO MEDICAL ENTERPRISES, INC. ELITE 18X18X18MM, STRAIGHT BRIDGE, 2 LEGS, INSERTER; BONE STAPLE

Catalog Number EL-1818S2

Device Problems Break (1069); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of event: unknown.(b)(4).Device is an instrument and is not implanted/explanted.A manufacturing investigation including a device history record review was performed for the received device.Visual inspection showed that the reported insertion stick broke on the upper part of the legs, right and left side.Implant-inserter assembly was not properly placed in the tray.Misplacement of the implant-inserter inside packaging is due to mishandling during shipping.The failure mode for this complaint has been confirmed (broken inserter).This issue has been investigated before and it was concluded that the root cause is the result of a combination of design, manufacturing, and supplied material factors.Efforts are in place to correct this issue.The device history record review was performed for bme lot number bmeel 160246.Date of manufacture/release to warehouse date: july 14, 2016.Expiration date: july 6, 2021.The review showed that two (2) nonconformance manufacturing reports (ncmrs) were generated during production.The first was for eight (8) insertion sticks that were found to have air pockets or voids after they were reworked.The second was generated during production for lot bmeel 160246 for (b)(4) implant kits that were found to have cracked insertion sticks during post sterilization inspection.Review of the device history record(s) showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.A device history record review was also performed for the parent lot, bme lot number 1602132027.No ncmrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was initially reported to synthes on march 1, 2017 that the elite inserter for the biomedical enterprises, inc.(bme) staple implant is cracked.The sales consultant discovered the issue on march 1, 2017 while inspecting the product but he was unsure how or when the instrument was damaged.The instrument was still in the original package.There was no patient or surgical involvement associated with the complaint event.Based on this information, this complaint was initially determined to be non-reportable.Visual inspection of the returned inserter by the manufacturer on april 6, 2017, revealed the inserter was broken on the upper part of the legs.The complaint condition was re-evaluated based on this observation and determined to be reportable.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The initial complaint was reviewed and found not reportable the information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.Clarification was obtained that the device was found received cracked and was in originally packaging.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.

Event Description

The initial complaint was reviewed and found not reportable the information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.Clarification was obtained that the device was found received cracked and was in originally packaging.

• Brand Name: ELITE 18X18X18MM, STRAIGHT BRIDGE, 2 LEGS, INSERTER
• Type of Device: BONE STAPLE
• Manufacturer (Section D): BIO MEDICAL ENTERPRISES, INC.; 14785 omicron dr # 205; san antonio TX 78245
• Manufacturer (Section G): BIO MEDICAL ENTERPRISES, INC.; 14785 omicron dr # 205; san antonio PA 78245
• Manufacturer Contact: michael cote ; 1302 wrights lange east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6529146
• MDR Text Key: 74152275
• Report Number: 1649263-2017-10007
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Expiration Date: 07/06/2021
• Device Catalogue Number: EL-1818S2
• Device Lot Number: BMEEL160246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1