MAUDE Adverse Event Report: PEGA MEDICAL INC. GAP ENDO-EXO MEDULLARY SYSTEM; GAP NAIL

Model Number	GAP-N56-28
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by the reporter indicated that the patient was told to partially weigh bear with support until there was bone healing, and wear an orthotic boot.Despite the indications to the patient, he went for a long unsupported walk and even climbed a set of stairs.Probably, the bone was not healed by the tenth-week post-op, which most likely lead to implant failure.The nature of the cases where the gap nails are frequently used (osteogenesis imperfecta, tibial pseudoarthrosis, or other skeletal dysplasias) increases the risk of device failure when the post-operative instructions are not followed.If weight limitations and post-operative partial weight-bearing are not considered, the risk of failure may increase.
Event or Problem Description
On (b)(6) 2021, the gap endo-exo medullary system nail gap-56-28 was implanted in the tibia of a patient with congenital tibial pseudoarthrosis.The nail was reported broken on (b)(6) 2021, 10 weeks and four days after implantation.

• Brand Name: GAP ENDO-EXO MEDULLARY SYSTEM
• Common Device Name: GAP NAIL
• Manufacturer (Section D): PEGA MEDICAL INC.; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• MDR Report Key: 12218708
• Report Number: 3000327445-2021-00005
• Device Sequence Number: 3962407
• Product Code: HSB
• UDI-Device Identifier: 07540194000866
• UDI-Public: (01)07540194000866(10)121218-011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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?: No
• Operator of Device: No Information
• Device Model Number: GAP-N56-28
• Device Catalogue Number: GAP-N56-28
• Device Lot Number: 121218-011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Weight: 52